+Άρθρο 25 Ευθύνες κατά μήκος της αξιακής αλυσίδας της ΤΝ
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Άρθρο 25 Ευθύνες κατά μήκος της αξιακής αλυσίδας της ΤΝ

1. Επισκόπηση

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Τίτλος	Κανονισμός
Άρθρο 25 1.	Οποιοσδήποτε διανομέας, εισαγωγέας, φορέας εφαρμογής ή άλλος τρίτος θεωρείται ότι είναι πάροχος συστήματος ΤΝ υψηλού κινδύνου για τους σκοπούς του παρόντος κανονισμού και υπόκειται στις υποχρεώσεις που ισχύουν για τον πάροχο δυνάμει του άρθρου 16, στις ακόλουθες περιστάσεις: α) εάν διαθέτει την επωνυμία ή το εμπορικό του σήμα σε σύστημα ΤΝ υψηλού κινδύνου που έχει ήδη διατεθεί στην αγορά ή τεθεί σε λειτουργία, υπό την επιφύλαξη συμβατικών ρυθμίσεων που ορίζουν ότι οι υποχρεώσεις κατανέμονται διαφορετικά· β) εάν επιφέρει ουσιαστική τροποποίηση σε σύστημα ΤΝ υψηλού κινδύνου που έχει ήδη διατεθεί στην αγορά ή έχει ήδη τεθεί σε λειτουργία κατά τρόπο που να παραμένει σύστημα ΤΝ υψηλού κινδύνου δυνάμει του άρθρου 6· γ) εάν τροποποιεί τον επιδιωκόμενο σκοπό συστήματος ΤΝ, συμπεριλαμβανομένου συστήματος ΤΝ γενικού σκοπού, που δεν έχει ταξινομηθεί ως υψηλού κινδύνου και έχει ήδη διατεθεί στην αγορά ή τεθεί σε λειτουργία κατά τρόπο ώστε το εν λόγω σύστημα ΤΝ να καταστεί σύστημα ΤΝ υψηλού κινδύνου σύμφωνα με το άρθρο 6.
Άρθρο 25 2.	Όταν συντρέχουν οι περιστάσεις που αναφέρονται στην παράγραφο 1, ο πάροχος που αρχικά διέθεσε το σύστημα ΤΝ στην αγορά ή το έθεσε σε λειτουργία δεν θεωρείται πλέον πάροχος του συγκεκριμένου συστήματος ΤΝ για τους σκοπούς του παρόντος κανονισμού. Ο εν λόγω αρχικός πάροχος συνεργάζεται στενά με νέους παρόχους και καθιστά διαθέσιμες τις απαραίτητες πληροφορίες και παρέχει την απαιτούμενη ευλόγως αναμενόμενη τεχνική πρόσβαση και άλλη βοήθεια για την εκπλήρωση των υποχρεώσεων που καθορίζονται στον παρόντα κανονισμό, ιδίως όσον αφορά την τήρηση της αξιολόγησης της συμμόρφωσης των συστημάτων ΤΝ υψηλού κινδύνου. Ειδικότερα, η υποχρέωση που καθορίζεται στο δεύτερο εδάφιο περιλαμβάνει, κατά περίπτωση για τους σκοπούς που προσδιορίζονται σε αυτό, τα ακόλουθα: α) διάθεση επαρκούς τεχνικού φακέλου για την αξιολόγηση της συμμόρφωσης με τις απαιτήσεις του άρθρου 16· β) ενημέρωση των νέων παρόχων όσον αφορά γνωστούς περιορισμούς και τρόπους αστοχίας· και γ) παροχή στοχευμένης τεχνικής πρόσβασης για τους νέους παρόχους, μεταξύ άλλων για δοκιμές και επικύρωση. Η παρούσα παράγραφος δεν εφαρμόζεται σε περιπτώσεις στις οποίες ο αρχικός πάροχος έχει διευκρινίσει σαφώς ότι το οικείο σύστημα ΤΝ δεν πρόκειται να μετατραπεί σε σύστημα ΤΝ υψηλού κινδύνου και, ως εκ τούτου, δεν εμπίπτει στην υποχρέωση συνεργασίας με τους νέους παρόχους και παράδοσης της τεκμηρίωσης.
Άρθρο 25 3.	Στην περίπτωση συστημάτων ΤΝ υψηλού κινδύνου που αποτελούν κατασκευαστικά στοιχεία ασφάλειας προϊόντων που καλύπτονται από την ενωσιακή νομοθεσία εναρμόνισης που παρατίθεται στο παράρτημα I τμήμα Α, ο κατασκευαστής του προϊόντος θεωρείται πάροχος του συστήματος ΤΝ υψηλού κινδύνου και υπόκειται στις υποχρεώσεις του άρθρου 16, εάν ισχύει μία από τις ακόλουθες περιστάσεις: α) το σύστημα ΤΝ υψηλού κινδύνου διατίθεται στην αγορά μαζί με το προϊόν υπό την επωνυμία ή το εμπορικό σήμα του κατασκευαστή του προϊόντος· β) το σύστημα ΤΝ υψηλού κινδύνου τίθεται σε λειτουργία υπό την επωνυμία ή το εμπορικό σήμα του κατασκευαστή του προϊόντος μετά τη διάθεση του προϊόντος στην αγορά.
Άρθρο 25 4.	Ο πάροχος συστήματος ΤΝ υψηλού κινδύνου και το τρίτο μέρος που παρέχει σύστημα ΤΝ, μοντέλο ΤΝ, εργαλεία, υπηρεσίες, κατασκευαστικά στοιχεία ή διαδικασίες που χρησιμοποιούνται ή ενσωματώνονται σε σύστημα ΤΝ υψηλού κινδύνου προσδιορίζουν, με γραπτή συμφωνία, τις απαραίτητες πληροφορίες, ικανότητες, τεχνική πρόσβαση και άλλη βοήθεια, με βάση τη γενικά αναγνωρισμένη εξέλιξη της τεχνολογίας, προκειμένου να μπορεί ο πάροχος του συστήματος ΤΝ υψηλού κινδύνου να συμμορφώνεται πλήρως με τις υποχρεώσεις που καθορίζονται στον παρόντα κανονισμό. Η παρούσα παράγραφος δεν ισχύει για τρίτα μέρη που καθιστούν προσβάσιμα στο κοινό εργαλεία, υπηρεσίες, διαδικασίες ή κατασκευαστικά στοιχεία ΤΝ, εκτός από μοντέλα ΤΝ γενικού σκοπού, στο πλαίσιο δωρεάν άδειας ανοικτού κώδικα. Η Υπηρεσία ΤΝ μπορεί να συντάσσει και να συστήνει προαιρετικούς πρότυπους όρους συμβολαίων μεταξύ παρόχων συστημάτων ΤΝ υψηλού κινδύνου και τρίτων μερών που παρέχουν εργαλεία, υπηρεσίες, κατασκευαστικά στοιχεία ή διαδικασίες που χρησιμοποιούνται ή ενσωματώνονται σε συστήματα ΤΝ υψηλού κινδύνου. Κατά την εκπόνηση των εν λόγω προαιρετικών πρότυπων όρων, η Υπηρεσία ΤΝ λαμβάνει υπόψη ενδεχόμενες συμβατικές απαιτήσεις που εφαρμόζονται σε συγκεκριμένους τομείς ή επιχειρηματικές περιπτώσεις. Οι προαιρετικοί πρότυποι όροι δημοσιεύονται και διατίθενται δωρεάν σε εύχρηστο ηλεκτρονικό μορφότυπο.
Άρθρο 25 5.	Οι παράγραφοι 2 και 3 δεν θίγουν την ανάγκη τήρησης και προστασίας των δικαιωμάτων διανοητικής ιδιοκτησίας, των εμπιστευτικών επιχειρηματικών πληροφοριών και του εμπορικού απορρήτου σύμφωνα με το ενωσιακό και το εθνικό δίκαιο.

1.1 Παραπομπές

1.2 Εντοπισμένες απαιτήσεις

1.3 Σχετικά πρότυπα

2. Εντοπισμένες απαιτήσεις

Απαιτήσεις
Πηγή	Απαίτηση

3. Σχετικά πρότυπα

Πρότυπα
Πηγή	Απαίτηση
SCF	Product Conformity Governance Description Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility) Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Regulatory requirements checklist for product development ∙ Legal review before release Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Product compliance requirements defined at project start ∙ Compliance validation before release ∙ Regulatory conformity records Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ Product conformity governance program (statutory, regulatory, certification requirements) ∙ Compliance gates in release management ∙ Conformity documentation (e.g., declarations of conformity) Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900) ∙ Regulatory affairs and product security integration ∙ Conformity assessment and certification management SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160). ▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments. Level 3 Well Defined Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners. ▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF	Product Conformity Governance Description Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility) Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Regulatory requirements checklist for product development ∙ Legal review before release Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Product compliance requirements defined at project start ∙ Compliance validation before release ∙ Regulatory conformity records Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ Product conformity governance program (statutory, regulatory, certification requirements) ∙ Compliance gates in release management ∙ Conformity documentation (e.g., declarations of conformity) Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900) ∙ Regulatory affairs and product security integration ∙ Conformity assessment and certification management SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160). ▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments. Level 3 Well Defined Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners. ▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF	Product Conformity Governance Description Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility) Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Regulatory requirements checklist for product development ∙ Legal review before release Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Product compliance requirements defined at project start ∙ Compliance validation before release ∙ Regulatory conformity records Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ Product conformity governance program (statutory, regulatory, certification requirements) ∙ Compliance gates in release management ∙ Conformity documentation (e.g., declarations of conformity) Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900) ∙ Regulatory affairs and product security integration ∙ Conformity assessment and certification management SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160). ▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments. Level 3 Well Defined Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners. ▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF	Product Conformity Governance Description Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility) Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Regulatory requirements checklist for product development ∙ Legal review before release Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Product compliance requirements defined at project start ∙ Compliance validation before release ∙ Regulatory conformity records Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ Product conformity governance program (statutory, regulatory, certification requirements) ∙ Compliance gates in release management ∙ Conformity documentation (e.g., declarations of conformity) Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900) ∙ Regulatory affairs and product security integration ∙ Conformity assessment and certification management SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160). ▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments. Level 3 Well Defined Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners. ▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF	Product Conformity Governance Description Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility) Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Regulatory requirements checklist for product development ∙ Legal review before release Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Product compliance requirements defined at project start ∙ Compliance validation before release ∙ Regulatory conformity records Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ Product conformity governance program (statutory, regulatory, certification requirements) ∙ Compliance gates in release management ∙ Conformity documentation (e.g., declarations of conformity) Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900) ∙ Regulatory affairs and product security integration ∙ Conformity assessment and certification management SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160). ▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments. Level 3 Well Defined Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners. ▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF	Product Conformity Governance Description Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility) Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Regulatory requirements checklist for product development ∙ Legal review before release Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Product compliance requirements defined at project start ∙ Compliance validation before release ∙ Regulatory conformity records Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ Product conformity governance program (statutory, regulatory, certification requirements) ∙ Compliance gates in release management ∙ Conformity documentation (e.g., declarations of conformity) Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900) ∙ Regulatory affairs and product security integration ∙ Conformity assessment and certification management SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160). ▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments. Level 3 Well Defined Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners. ▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's: (1) Use case(s); and (2) Geographic markets. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.

Builddate: 27.07.2026 00:00:00 -Doknr: CELEX:32024R1689
EULAW -
European Regulation published on http://eur-lex.europa.eu/